<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220206053952N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-10</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the efficacy of auditory-visual attention training in tinnitus</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the efficacy of rehabilitation using auditory-visual attentional training in adults with chronic tinnitus: A quantitative electroencephalography (qEEG) study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple Random Sampling, Blinding description: Only participants are withhold until the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tinnitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The attention training with the simultaneous auditory-visual stimulus is done. The training is based on Posner's attention theory and is designed as a mobile application. After logging into the program, the subjects perform a daily evaluation of their tinnitus and then the training has begun. First, simultaneous auditory-visual cues are presented and then the subject should choose the correct answer in the next part of the training. The numbers and colors are used as the auditory and visual stimulus respectively. The subject directs to the next level after choosing the correct answer. The training levels are designed from easy to hard by decreasing the time of the cues and increasing the number of cues and items (the numbers and colors) in the training. The reaction time, error rate, and level progress are saved into the software database. Intervention 2: First control group: The attention training is done the same as in the intervention group, but using the auditory-only stimulus. Intervention 3: First control group: The attention training is done the same as in the intervention group, but using the visual-only stimulus.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It would be specified by the study supervisor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Namvar Arefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Audiology Department, Rehabilitation Science School of Iran University of Medical Sciences , Madadkaran St., Shah Nazari St., Madar Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷۱۵۴۵۹</zip>
        <telephone>009822227124</telephone>
        <email>hnamvar91@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnoush Jarollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Madadkaran Str., Shahnazari Ave., Madar Sqr., Mirdamad Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷۱۵۴۵۹</zip>
        <telephone>+98 21 2225 0541</telephone>
        <email>jarollahi.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Right-handedness
Chronic tinnitus (more than 6 months)
Normal hearing (hearing thresholds less than 25 dB HL)  in conventional audiometry (250-8000 Hz)
Not using anti-depressant, anti-seizure, and anesthetic drugs
No history of neurologic disease such as brain tumors, Meniere disease, chronic headache, and otosclerosis
No major psychological problem seeking to professional</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H93.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tinnitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The attention training with the simultaneous auditory-visual stimulus is done. The training is based on Posner's attention theory and is designed as a mobile application. After logging into the program, the subjects perform a daily evaluation of their tinnitus and then the training has begun. First, simultaneous auditory-visual cues are presented and then the subject should choose the correct answer in the next part of the training. The numbers and colors are used as the auditory and visual stimulus respectively. The subject directs to the next level after choosing the correct answer. The training levels are designed from easy to hard by decreasing the time of the cues and increasing the number of cues and items (the numbers and colors) in the training. The reaction time, error rate, and level progress are saved into the software database.</i_keyword>
      <i_keyword>First control group: The attention training is done the same as in the intervention group, but using the auditory-only stimulus.</i_keyword>
      <i_keyword>First control group: The attention training is done the same as in the intervention group, but using the visual-only stimulus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reaction time in Attention Network Test (ANT). Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Attention Network Test (ANT) software.</prim_outcome>
      <prim_outcome>Error rate in Attention Network Test (ANT). Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Attention Network Test (ANT) software.</prim_outcome>
      <prim_outcome>The amplitude of P300 electrophysiology response. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>The latency of P300 electrophysiology response. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>The mean frequency of electroencephalogram (EEG) waves. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>The absolute power of electroencephalogram (EEG) waves. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>The relative power of electroencephalogram (EEG) waves. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>Electroencephalogram (EEG) activity at the region of interests (ROIs). Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: 21 channel electroencephalography device.</prim_outcome>
      <prim_outcome>Reaction time in the Stroop task. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Stroop task software.</prim_outcome>
      <prim_outcome>Error rate in the Stroop task. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Stroop task software.</prim_outcome>
      <prim_outcome>Reaction time in the the Test of Attention in Listening (TAiL). Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Test of Attention in Listening (TAiL) software.</prim_outcome>
      <prim_outcome>Error rate in the the Test of Attention in Listening (TAiL). Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Test of Attention in Listening (TAiL) software.</prim_outcome>
      <prim_outcome>Hospital Anxiety and Depression Scale (HADS) questionnaire score. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.</prim_outcome>
      <prim_outcome>Tinnitus Handicap Questionnaire (THQ) score. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Tinnitus Handicap Questionnaire (THQ).</prim_outcome>
      <prim_outcome>Tinnitus annoynce. Timepoint: At the beginning of the study and daily measurement during 21 days of rehabilitation (attention training). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Tinnitus loudness. Timepoint: At the beginning of the study and daily measurement during 21 days of rehabilitation (attention training). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Tinnitus loudness. Timepoint: At the beginning of the study and 21 days after rehabilitation (attention training). Method of measurement: Psychoacoustic evaluation of tinnitus with audiometer device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway, Near Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
